Jacket for jet injection ampoules



y 14, 1953 R. P. SCHERER 2 38 JACKET FOR JET INJECTION AMPOULES FiledMay 14, 1949 .30 3 Z2 Z2 [5 22 1 151 v a I I I ll: s

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Patented July 14 1953 JACKET FOR JET INJECTION AMPOULES Robert PauliScherer, Detroit, Mich., assignor to R. P. Scherer Corporation, Detroit,Mich., a

corporation of Michigan Application May 14, 1949, Serial N 0. 93,281

5 Claims.

This invention relates to a jacket for receiving, protecting and scalingin sterile condition that type of hypodermic jet injection ampuledisclosed and claimed in my copending application, Serial No. 93,282,filed May 14, 1949, when the ampule is used in jet therapy as disclosedand claimed in my copending application, Serial No. 77,517, filedFebruary 21, 1949.

These jet injection ampules are adapted to contain liquid medicament anda follower which acts as a piston, the follower being in an open end ofthe ampule which is cylindrical in form and has its other end closed.The closed end of the jet ampule is pierced by a jet discharge orificeon the order of .002 to .005 diameter and the purpose of the ampule isto effect a jet type hypodermic injection by means of a holder andactuating device or hypo jet injector for the amlpule which holds thecylindrical container of the ampule while forcing the followerdownwardly under pressure and/or impact, thereby ejecting liquidmedicament through the discharge orifice in the form of a true jethaving the required power to penetrate through the epidermis of a humanbeing or animal and then continue penetration to the fat tissues, fasciaor muscles depending on the jet velocity and other factors, without thenecessity of using a hypodermic needle for first producing an openingthrough the epidermis. In this way the jet of liquid is injected to asubcutaneous position, to the fascia or to an intramuscular positionwithout the attendant pain and discomfort of the usual hypodermicneedle. The holder'and actuating device above referred to constitutes ahypo jet injector disclosed and claimed in my copending application,Serial No. 94,579, filed May 21, 1949.

An approach was made toward jet injection (see the following Lockhartpatents) Number Date June 22, 1943. June 22, 1943. July 31, 1945.

April 16, 1946.

but I have found that the apparatus disclosed in those patents does notaccomplish the results expected, particularly when quantities of liquidit in the hypo jet injector and operates the pressure producingmechanism to effect the jet injection operation. The charged jetinjection ampule, that is, the container with the medicament in it andthe follower behind the medicament, presents a problem with respect toprotection against contamination and against leakage or evaporation ofthe medicament through its minute jet discharge orifice. The jetorifice, due to its minute size, can not readily be plugged but must becovered or otherwise sealed with a seal that is readily removable. It isalso highly desirable to have the charged jet ampule delivered to theinjector in a sterile condition and this applies particularly to theclosed end of the ampule which contacts the epidermis during thehypodermic jet injection operation and which might introduce bacterialcontamination through the opening formed in the epidermis by the jet ofmedicament. To safeguard against such a happening the ampule should besterilized when charged and then sealed against subsequent bacterialcontamination, or sterilized after sealing as by subjection to asuitable electric discharge or germ killing electric field. 7

It is also desirable to insure that the follower will remain in itsproper position in the jet ampule Without any possibility of accidentaldislodgment, and to accomplish all these desirable results the mainobject of my present invention is to provide a jacket which will meetthe enumerated requirements.

Another object is to provide a jacket in the form of a cylinder havingone end closed, and a removable cap on the other end, the jacket and capenclosing the jet ampule completely.

Still anotherobject is to provide a resilient sealing means in thejacket which effectively seals the jet orifice of the jet ampule againstleakage of the medicament therefrom.

A further object is to provide a cap which can be connected with thejacket by a simple spinning or bending operation around the periphery ofthe cap and to provide a gasket or sealing means for the cap withrespect to the: jacket which produces a perfect hermetic seal of theentire charged jet ampule within the jacket, the jacket and its cap alsopreventing dislodgment of the follower due to expansion of themedicament caused by a rise in temperature or due to any other factorsthat might be involved.

With these and other objects in view, my invention consists in theconstruction, arrangement and combination of the various parts of my jetinjection ampule jacket whereby the objects contemplated are attained ashereinafter more fully set forth, pointed out in my claims andillustrated in the accompanying drawings wherein:

Figure 1 is an enlarged exploded perspective view of the elements of myjet injection ampule and my jacket therefor;

Figure 2 is an exploded sectional View thereof shown on a still largerscale;

Figure 3 shows the same parts partially assembled, the jet ampule filledwith liquid, the follower placed therein and the jet discharge orificesealing element placed in the cap for the jacket;

Figure 4 shows a further step in the assembly, the jet injection ampulebeing in place in the jacket and the cap dropped onto the jacket;

Figure 5 illustrates the last step with the cap and its sealing elementforced to its final position on the jacket and the cap partially lockedin position by spinning its peripheral edge to final position;

Figure 6 is a perspective view of the jacketed jet injection ampule,this view being full size for a 1 cc. dosage of medicament although ofcourse the size can vary considerably to suit different dosages, 1 cc.being a practical size for maximum dosage with a practical degree ofcon- I centration of medicament in the vehicle liquid;

Figure '7 is a side elevation of the jacketed ampule showing it beingassociated with a cap remover for the purpose of removing the cap sothat the charged ampule can be transferred from the jacket to theinjector when the hypodermic injection is to be made; and

Figures 8 and 9 are cross sections showing modifications.

On the accompanying drawing I have used the reference numeral Ill toindicate the container portion of the ampule. The container may be madeof sheet metal or molded of plastic or glass and is illustrated ashaving a constricted lower end i2, a shoulder being formed at it toengage a shouldered surface in the injector when the ampule is receivedtherein. The constricted end l2 may assume other shapes as disclosed inmy first above-mentioned co-pending application and has a minute jetdischarge orifice it which on the average would be about .00325" indiameter.

The container m is adapted to contain a liquid l8 which is a desiredmedicament and which is retained in the container 13 by a plug-likefollower or pistonZil. The follower is preferably in the form of acup-shaped piston as illustrated. The follower serves as a piston whenthe ampule is held in the injector and the follower is forced toward thedischarge orifice it.

The follower may be made of rubber, neoprene or similar rubber-likesubstance so that it seals well in relation to the interior surface ofthe container It and this container acts as a cylinder in conjunctionwith the follower 20 acting as a piston for effecting the displacementof the medicament from the jet ampule. Obviously the force of theplunger against the follower 29 may be sufiiciently great for generatingpressures in thousands of pounds per square inch on the liquid 18 sothat the velocity of the jet of liquid issuing from the orifice it issufficient for, in some cases epidermic penetration and in other casesintra muscular penetration.

The present invention contemplates particularly a jacket for the chargedjet ampule l9-i8-20 and this jacket may take the form of cylinder 22 ofaluminum or other sheet metal having a closed end 24 and an open endsurrounded by an out-turned annular fiange 26.

j The complete jacket further includes an orifice sealing element 36 inthe form of a disk of neoprene or the like and a thin sheet metal cap 324 having a peripheral flange 33. The cap may be made of aluminum or anysuitable metal that will permit the flange 33 to be bent to the finalposition shown at the left side in Figure 5 by means of a rollingoperation or the like. 7

In the assembly of the jet ampule in the jacket, the sealing disk 36 isfirst inserted into the cap 32 as shown in Figure 3 and the charged jetampule is then turned end-for-end and permitted to drop into position asshown in Figure 4. The cap is then placed loosely in position on thejacket whereupon the disk 30 is spaced from the flange 26 because thelower end of the ampule is supported by the wall 24. The purpose of thisarrangement is so that the disk 33 can be forced to the final positionof Figure 5 whereby it is under compression on the flange 25 and overthe orifice l6 as shown so as to effect an adequate seal for the jetorifice of the ampule with respect to atmosphere. The spinning operationon the flange 33 causes it to bend as indicated at 33a. This causes thedisk 3b to form a hermetic seal between the jacket 22 and its cap 32 aswell as for the orifice, the final jacketed ampule being shown in Figure6.

A modification is illustrated in Figure 8 in which the same jacket 22 isused having the flange '26 but a modified ampule Elia is used having aflange Etc overlying the fiange 26. The ampule ma has a rounded lowerend 12a pierced as at it to form a desirable orifice {E and the orificeis sealed within the capped jacket by means of a disk 34% in the bottomof the jacket instead of the disk 3'3 in the cap. Substantially the samecap 32 is used having the depending flange 33 turned in at 33c but adifferent arrangement of seal between the cap and the jacket is providedin the form of a band 38a of resilient material such as rubber or thelike against which the turned-in edge 33a of the flange 33 engages withsufficient force to compress the material 30a. This material may beneoprene or the like painted around the jacket 22 under the rim 26 orthe jacket can be dipped in a liquid composition that hardens afterdipping.

This figure also illustrates a modified form of follower piston Zlla inthe form of a solid plug rounded at its lower end to fit the round endl2a of the ampule ltd when the plug is all of the way down as a resultof operation of the ampule in the injector.

In Figure 9 another modification is shown in which the same type offollower 2b as disclosed in Figures 1, 2 and 3 is used in an ampule ofthe general type shown in Figure 8 but instead of the seal 300: asealing disk 3% is used which may be comparable to the disk 3% or extendover the edges of the fianges 2t and 23a and under the flange 28 asillustrated if desired.

With either the form of invention shown in Figure a or Figure 8 theorifice It is effectively sealed when the ampule is forced to its finalposition against either the disk 35) of Figure 4 or the disk 35 ofFigure 8 by securing the cap 32 in position.

A cap 32 of the character disclosed is readily removable insubstantially the same manner as the removal of a crown cap from abottle. Figure '7 illustrates a cap remover element 36 which may beU-shaped in cross section and secured to a supporting surface 38. Theelement 36 has a lip 43 under which the edge of the cap 32 is engagedwhereupon by swinging the ampule downwardly as indicated by the arrow Athe cap is pried off the jacket and the charged ampule 5, may be droppedout of the jacket 22 and into the hypo jet injector. For convenience,the support 38 of Figure '7 is the injector itself.

From the foregoing specification it is obvious that I have provided ajacket which contains means to seal the jet orifice of a hypo jetinjection ampule and also hermetically seals the entire charged ampuleagainst contamination between the time of filling and assembly at thefactory and the time of use by the doctor or patient. After the ampuleis removed from the jacket it is ready for instant use and insurance ishad that the end I?! which contacts the skin of the patient surroundingthe point of injection will be in sterile condition so as to minimizethe possibility of bacteria entering the body through the injectionopening made by the jet of medicament that issues from the ampule whenthe injector is operated.

Some changes may be made in the construction and arrangement of theparts of my jet injection ampule jacket without departing from the realspirit and purpose of my invention, and it is my intention to cover bymy claims such modified forms of structure or use of mechanicalequivalents as may be reasonably included within their scope.

I claim as my invention:

1. In a jacket for a jet injection ampule, a cylindrical element closedatone end and open at the other end, a sealing element for said ampulelocated in the closed end of said cylin drical element, and a removablecap for said cylindrical element, said cap retaining said ampule in saidcylindrical element with a jet orifice thereof sealed by compressingsaid sealing element, said cap having an inturned edge to retain it inposition on said cylindrical element and said cylindrical element havinga flange received in said inturned edge, and a resilient sealing bandaround said cylindrical element below said flange and adapted to becompressed by the edge of said cap when so turned in.

2. In a jacket for a jet injection ampule con-' sisting of a containerprovided with a minute jet orifice, a cylindrical container having aclosed end, sealing means within said closed end for sealing said jetorifice, the other end of said cylindrical container being open andprovided with an outturned annular flange, a can for said cylindricalcontainer having a periphery adapted to be bent under said flange, saidcap in its installed position forcing said ampule into pressureengagement with said sealing element, and sealing means around saidcylindrical container below said flange and contacted by the turned-inedge of said cap to form a hermetic seal between the cylindricalcontainer and the cap.

3. For use with a jet injection ampule of the type comprising a cylinderhaving medicament therein, a minute jet discharge orifice at one end ofthe cylinder and a follower in the other end flange at the opposite end,said cylindrical ele' ment being adapted to receive said ampule with itsjet discharge orifice adjacent the closed end of the cylindricalelement, sealing means interposed between said closed end and said jetdischarge'orifice, a cap for retaining said ampule in position with saidsealing means under compression, and a gasket between said cylindricalelement and said cap.

4. The combination of a jet injection ampule and a container thereforwherein the container completely encloses said jet injection ampule,said ampule having one end reduced in diameter and closed except for aminute jet discharge orifice, said container having one end closed andbeing open at the other end, a sealing element for said dischargeorifice of said ampule, and a cap for said container, said sealingelement being located in said cap and spanning both said container andsaid closed end of said ampule with the reduced portion thereof enteringsaid sealing element to insure it sealing said discharge orifice, saidcap being removable from the container for permitting disassociation ofthe discharge orifice of the ampule from said sealing element wherebythe container, cap and sealing element may be discarded and the ampuleis thereupon completely ready for use and may be dropped out of thecontainer with said discharge orifice foremost into a jet injector foruse therein.

. 5. The combination of a jet injection ampule and a cylindrical elementto serve as a container therefor, said ampule having a closed endprovided with a jet discharge orifice, said cylindrical element havingone end closed and open at the other end, a sealing element for said jetdischarge orifice of said ampule, a removable cap: for said cylindricalelement, said sealing element being located in said cap, the length ofthe cylindrical element being such in respect to the length of theampule that when the ampule is placed within the cylindrical element andforced to a seated position on said sealing element by said cap, saidclosed end of said ampule will enter the surface of said sealing elementwhereby the sealing element will be under compression across suchorifice, said cap retaining said ampule in said cylindrical element withsaid orifice thereof, and with said cap of the cylinder; a jacketcomprising a cylindrical element having a closed end and an outurnedrelative to said cylindrical element, sealed by said sealing element.

ROBERT PAULI SCHERER.

References Cited in the file of this patent UNITED STATES PATENTS NumberName Date 723,552 Sachs Mar. 24, 1903 1,669,729 Gans May 15, 19281,872,864 Yarcho Aug. 23, 1932 1,945,126 Upjohn Jan. 30, 1934 2,007,454May July 9, 1935 2,176,042 Pittenger Oct. 10, 1939 2,300,070 Smith Oct.27, 1942 2,314,167 Shaw Mar. 16, 1943

